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Home Industry News Novo Nordisk offers FDA liraglutide update

Novo Nordisk offers FDA liraglutide update

5th January 2010

Novo Nordisk has noted that formal feedback from the Food and Drug Administration (FDA) regarding its once-daily human Glucagon-Like Peptide-1 analogue liraglutide is expected in the coming weeks.

In a statement, the pharmaceutical company explained that it is continuing a “constructive dialogue” with the body regarding the regulatory process for the therapy.

Novo Nordisk said that it expects to be able to offer an update on the process for the drug – which was developed for the treatment of type 2 diabetes – in connection with the announcement of its results for the 2009 financial year on February 2nd, if no formal feedback is received before that time.

Last month, Novo Nordisk announced that it has signed an agreement with ZymoGenetics where the former in-licenses a fully-human anti-IL21 monoclonal antibody (IL-21 mAb) from the latter.

Under the terms of the deal, Novo Nordisk has agreed to pay an upfront sum of $24 million (14.85 million pounds) to ZymoGenetics

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